SKIP for PA Study: Team and Leadership Level Implementation Support for Collaborative Care

NCT04946253 | Recruiting DMC

• 2 other identifiers: STUDY20080207R01MH124914
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 2

Brief Summary

In a prior application (MH064372), the investigators' treatment research program (Services for Kids In Primary-care, SKIP) developed and tested a chronic care model-based intervention, called Doctor Office Collaborative Care (DOCC), that was found to be effective in the management of childhood behavior problems and comorbid ADHD. In the "SKIP for PA Study", the investigators propose to conduct a randomized clinical trial to evaluate the effects of team- and practice leadership-level implementation strategies designed to enhance the use and uptake of DOCC in diverse pediatric primary care offices.

Conditions

Child Behavior Problem; Attention Deficit and Disruptive Behavior Disorders

Keywords

Oppositional Defiant Disorder; Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (19)

• Total number of DOCC encounters

  As part of a short checklist-style progress note completed after each service contact and housed in the study's web-based patient registry dashboard, providers will document each DOCC encounter delivered to each family. These encounters include referral, assessment, treatment or medication delivery, medication or treatment review/monitoring, case management, review of emergent symptoms, and care management and consultation meetings involving a family member. Investigators will report the total number of DOCC encounters delivered to each family during the intervention phase.

  Throughout services after each contact, up to 12 months

• Care management competencies and functions

  The Mental Health Practice Readiness Inventory will be completed to document the degree to which a practice has the organizational and individual competencies needed to support integrated BH care. All 32 items reflect the diverse activities (e.g., workflows, financing, service delivery, care coordination) suggested as functions for PCPs (scale: 0 = no function exists; 1 = some function; 2 = function is complete). Thus, total scale scores can range from 0 to 64. Investigators will use scores for each of the 32 competency items (range 0-2) and the total score (range 0-64) to describe the overall level of collaborative care competencies achieved per practice.

  At provider baseline

• Change from baseline in care management competencies and functions at 6 months

  The Mental Health Practice Readiness Inventory will be completed to document the degree to which a practice has the organizational and individual competencies needed to support integrated BH care. All 32 items reflect the diverse activities (e.g., workflows, financing, service delivery, care coordination) suggested as functions for PCPs (scale: 0 = no function exists; 1 = some function; 2 = function is complete). Thus, total scale scores can range from 0 to 64. Investigators will use scores for each of the 32 competency items (range 0-2) and the total score (range 0-64) to describe the overall level of collaborative care competencies achieved per practice.

  6 months after provider baseline

• Change from baseline in care management competencies and functions at 12 months

  The Mental Health Practice Readiness Inventory will be completed to document the degree to which a practice has the organizational and individual competencies needed to support integrated BH care. All 32 items reflect the diverse activities (e.g., workflows, financing, service delivery, care coordination) suggested as functions for PCPs (scale: 0 = no function exists; 1 = some function; 2 = function is complete). Thus, total scale scores can range from 0 to 64. Investigators will use scores for each of the 32 competency items (range 0-2) and the total score (range 0-64) to describe the overall level of collaborative care competencies achieved per practice.

  12 months after provider baseline

• Change from baseline in care management competencies and functions at 18 months

  The Mental Health Practice Readiness Inventory will be completed to document the degree to which a practice has the organizational and individual competencies needed to support integrated BH care. All 32 items reflect the diverse activities (e.g., workflows, financing, service delivery, care coordination) suggested as functions for PCPs (scale: 0 = no function exists; 1 = some function; 2 = function is complete). Thus, total scale scores can range from 0 to 64. Investigators will use scores for each of the 32 competency items (range 0-2) and the total score (range 0-64) to describe the overall level of collaborative care competencies achieved per practice.

  18 months after provider baseline

• Change from baseline in care management competencies and functions at 24 months

  The Mental Health Practice Readiness Inventory will be completed to document the degree to which a practice has the organizational and individual competencies needed to support integrated BH care. All 32 items reflect the diverse activities (e.g., workflows, financing, service delivery, care coordination) suggested as functions for PCPs (scale: 0 = no function exists; 1 = some function; 2 = function is complete). Thus, total scale scores can range from 0 to 64. Investigators will use scores for each of the 32 competency items (range 0-2) and the total score (range 0-64) to describe the overall level of collaborative care competencies achieved per practice.

  24 months after provider baseline

• Severity of ADHD, ODD, CD, and ANX/DEP symptoms at home and in community

  To assess the severity of the child's behavioral and emotional problems, the Vanderbilt ADHD Diagnostic Rating Scale will be completed by caregivers. The VADPRS includes 5 symptom severity subscales, each with a varying number of items: (hyperactivity/impulsivity (n=9), inattention (n=9), oppositional behavior (n=7), conduct problems (n=15), and anxiety/depression (n=7). The scores for the hyperactivity/impulsivity and inattention subscales are often aggregated to create an overall ADHD scale factor total score. Individual items are rated on a 4-point Likert scale (0 = never; 1 = occasionally; 2 = often; 3 = very often). There is also a performance (impairment) subscale (n=7) used to determine whether a child would meet clinical criteria for a given disorder. The range of scores per factor are as follows: hyperactivity/impulsivity (27), inattention (27), oppositional behavior (21), conduct problems (45), anxiety/depression (21) ,and performance (24).

  At caregiver baseline

• Change from baseline in severity of ADHD, ODD, CD, and ANX/DEP symptoms at home and in community at 3 months

  To assess the severity of the child's behavioral and emotional problems, the Vanderbilt ADHD Diagnostic Rating Scale will be completed by caregivers. The VADPRS includes 5 symptom severity subscales, each with a varying number of items: (hyperactivity/impulsivity (n=9), inattention (n=9), oppositional behavior (n=7), conduct problems (n=15), and anxiety/depression (n=7). The scores for the hyperactivity/impulsivity and inattention subscales are often aggregated to create an overall ADHD scale factor total score. Individual items are rated on a 4-point Likert scale (0 = never; 1 = occasionally; 2 = often; 3 = very often). There is also a performance (impairment) subscale (n=7) used to determine whether a child would meet clinical criteria for a given disorder. The range of scores per factor are as follows: hyperactivity/impulsivity (27), inattention (27), oppositional behavior (21), conduct problems (45), anxiety/depression (21) ,and performance (24).

  3 months after caregiver baseline

• Change from baseline in severity of ADHD, ODD, CD, and ANX/DEP symptoms at home and in community at 6 months

  To assess the severity of the child's behavioral and emotional problems, the Vanderbilt ADHD Diagnostic Rating Scale will be completed by caregivers. The VADPRS includes 5 symptom severity subscales, each with a varying number of items: (hyperactivity/impulsivity (n=9), inattention (n=9), oppositional behavior (n=7), conduct problems (n=15), and anxiety/depression (n=7). The scores for the hyperactivity/impulsivity and inattention subscales are often aggregated to create an overall ADHD scale factor total score. Individual items are rated on a 4-point Likert scale (0 = never; 1 = occasionally; 2 = often; 3 = very often). There is also a performance (impairment) subscale (n=7) used to determine whether a child would meet clinical criteria for a given disorder. The range of scores per factor are as follows: hyperactivity/impulsivity (27), inattention (27), oppositional behavior (21), conduct problems (45), anxiety/depression (21) ,and performance (24).

  6 months after caregiver baseline

• Change from baseline in severity of ADHD, ODD, CD, and ANX/DEP symptoms at home and in community at 12 months

  To assess the severity of the child's behavioral and emotional problems, the Vanderbilt ADHD Diagnostic Rating Scale will be completed by caregivers. The VADPRS includes 5 symptom severity subscales, each with a varying number of items: (hyperactivity/impulsivity (n=9), inattention (n=9), oppositional behavior (n=7), conduct problems (n=15), and anxiety/depression (n=7). The scores for the hyperactivity/impulsivity and inattention subscales are often aggregated to create an overall ADHD scale factor total score. Individual items are rated on a 4-point Likert scale (0 = never; 1 = occasionally; 2 = often; 3 = very often). There is also a performance (impairment) subscale (n=7) used to determine whether a child would meet clinical criteria for a given disorder. The range of scores per factor are as follows: hyperactivity/impulsivity (27), inattention (27), oppositional behavior (21), conduct problems (45), anxiety/depression (21) ,and performance (24).

  12 months after caregiver baseline

• Severity of ADHD, ODD/CD, and ANX/DEP symptoms at school

  Paralleling the VADPRS, the VADTRS will be completed by teachers. This version includes 3 of the same subscales in the parent version -- hyperactivity/impulsivity (n=9), inattention (n=9), and anxiety/depression (n=7) -- but it also includes an aggregated oppositional/conduct scale (n=10 items). Scores for the hyperactivity/impulsivity and inattention subscales are often aggregated to create an overall ADHD scale factor total score. Individual items are rated on a 4-point Likert scale (0 = never; 1 = occasionally; 2 = often; 3 = very often). There is also a performance subscale (n=8 items) that is used to determine whether a child would meet clinical criteria for a given disorder. The range of scores per factor are as follows: hyperactivity/impulsivity (27), inattention (27), oppositional/conduct problems (30), anxiety/depression (21) ,and performance (24). Practices will continue to separately request their own forms during services (e.g., for medication monitoring).

  At teacher baseline

• Change from baseline in severity of ADHD, ODD/CD, and ANX/DEP symptoms at school at 3 months

  Paralleling the VADPRS, the VADTRS will be completed by teachers. This version includes 3 of the same subscales in the parent version -- hyperactivity/impulsivity (n=9), inattention (n=9), and anxiety/depression (n=7) -- but it also includes an aggregated oppositional/conduct scale (n=10 items). Scores for the hyperactivity/impulsivity and inattention subscales are often aggregated to create an overall ADHD scale factor total score. Individual items are rated on a 4-point Likert scale (0 = never; 1 = occasionally; 2 = often; 3 = very often). There is also a performance subscale (n=8 items) that is used to determine whether a child would meet clinical criteria for a given disorder. The range of scores per factor are as follows: hyperactivity/impulsivity (27), inattention (27), oppositional/conduct problems (30), anxiety/depression (21) ,and performance (24). Practices will continue to separately request their own forms during services (e.g., for medication monitoring).

  3 months after teacher baseline

• Change from baseline in severity of ADHD, ODD/CD, and ANX/DEP symptoms at school at 6 months

  Paralleling the VADPRS, the VADTRS will be completed by teachers. This version includes 3 of the same subscales in the parent version -- hyperactivity/impulsivity (n=9), inattention (n=9), and anxiety/depression (n=7) -- but it also includes an aggregated oppositional/conduct scale (n=10 items). Scores for the hyperactivity/impulsivity and inattention subscales are often aggregated to create an overall ADHD scale factor total score. Individual items are rated on a 4-point Likert scale (0 = never; 1 = occasionally; 2 = often; 3 = very often). There is also a performance subscale (n=8 items) that is used to determine whether a child would meet clinical criteria for a given disorder. The range of scores per factor are as follows: hyperactivity/impulsivity (27), inattention (27), oppositional/conduct problems (30), anxiety/depression (21) ,and performance (24). Practices will continue to separately request their own forms during services (e.g., for medication monitoring).

  6 months after teacher baseline

• Change from baseline in severity of ADHD, ODD/CD, and ANX/DEP symptoms at school at 12 months

  Paralleling the VADPRS, the VADTRS will be completed by teachers. This version includes 3 of the same subscales in the parent version -- hyperactivity/impulsivity (n=9), inattention (n=9), and anxiety/depression (n=7) -- but it also includes an aggregated oppositional/conduct scale (n=10 items). Scores for the hyperactivity/impulsivity and inattention subscales are often aggregated to create an overall ADHD scale factor total score. Individual items are rated on a 4-point Likert scale (0 = never; 1 = occasionally; 2 = often; 3 = very often). There is also a performance subscale (n=8 items) that is used to determine whether a child would meet clinical criteria for a given disorder. The range of scores per factor are as follows: hyperactivity/impulsivity (27), inattention (27), oppositional/conduct problems (30), anxiety/depression (21) ,and performance (24). Practices will continue to separately request their own forms during services (e.g., for medication monitoring).

  12 months after teacher baseline

• Pediatric Health Quality

  Caregivers will complete the Pediatric Quality of Life (PEDS-QL) to measure health-related quality of life which includes 4 subscales: health/physical status (n=8), emotional health (n=5), school health (n=5), and social health (n=5). All items are rated on a 5-point Likert scale (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). These subscales have very good reliability and treatment validity and are sensitive to the DOCC EBP.

  At caregiver baseline

• Change from baseline in Pediatric Health Quality at 3 months

  Caregivers will complete the Pediatric Quality of Life (PEDS-QL) to measure health-related quality of life which includes 4 subscales: health/physical status (n=8), emotional health (n=5), school health (n=5), and social health (n=5). All items are rated on a 5-point Likert scale (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). These subscales have very good reliability and treatment validity and are sensitive to the DOCC EBP.

  3 months after caregiver baseline

• Change from baseline in Pediatric Health Quality at 3 months

  Caregivers will complete the Pediatric Quality of Life (PEDS-QL) to measure health-related quality of life which includes 4 subscales: health/physical status (n=8), emotional health (n=5), school health (n=5), and social health (n=5). All items are rated on a 5-point Likert scale (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). These subscales have very good reliability and treatment validity and are sensitive to the DOCC EBP.

  6 months after caregiver baseline

• Change from baseline in Pediatric Health Quality at 12 months

  Caregivers will complete the Pediatric Quality of Life (PEDS-QL) to measure health-related quality of life which includes 4 subscales: health/physical status (n=8), emotional health (n=5), school health (n=5), and social health (n=5). All items are rated on a 5-point Likert scale (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). These subscales have very good reliability and treatment validity and are sensitive to the DOCC EBP.

  12 months after caregiver baseline

• Professional perceptions of study experiences at 18 months

  Professionals will be invited to participate in an 18-month qualitative interview after they complete their 18-month online assessment. The purpose of this research interview is to provide feedback about their experiences with different aspects of this study, such as: learning and using the DOCC intervention, working as a team, participating any facilitation calls, and completing our research tasks. The interview gives us unique information about their perspective on these topics that can help us extend what we can learn from their surveys and then modify or tailor any of these methods to better support feasibility and acceptability. All responses will be thematically coded and summarized for interpretation.

  18 months after professional baseline

Study Arms (4)

DOCC with standard implementation (No TEAM or LEAD)

ACTIVE COMPARATOR

Practices in this arm will receive DOCC materials/training and technical support, but will not receive care team coaching/consultation (TEAM) or practice leadership facilitation (LEAD) after the training phase.

Behavioral: DOCC: Evidence-based treatment for disruptive behavior and ADHD

DOCC with TEAM implementation

EXPERIMENTAL

Practices in this arm will receive DOCC training and materials and one type of implementation support after the training: coaching/consultation for the provider care team (TEAM).

Behavioral: DOCC: Evidence-based treatment for disruptive behavior and ADHD; Behavioral: TEAM: Implementation support strategies at the care team level following standard implementation of DOCC

DOCC with LEAD implementation

EXPERIMENTAL

Practices in this arm will receive DOCC training and materials and only one type of implementation support after the training: facilitation for practice leadership (LEAD).

Behavioral: DOCC: Evidence-based treatment for disruptive behavior and ADHD; Behavioral: Implementation support strategies at the leadership level following standard implementation of DOCC

DOCC with TEAM + LEAD implementation

EXPERIMENTAL

Practices in this arm will receive DOCC training and materials and both types of implementation support after the training: coaching/consultation for the provider care team (TEAM) and facilitation for practice leadership (LEAD).

Behavioral: DOCC: Evidence-based treatment for disruptive behavior and ADHD; Behavioral: TEAM: Implementation support strategies at the care team level following standard implementation of DOCC; Behavioral: Implementation support strategies at the leadership level following standard implementation of DOCC

Interventions

TEAM: Implementation support strategies at the care team level following standard implementation of DOCC BEHAVIORAL

Practices will learn and then deliver DOCC in treatment sessions with caregivers and/or children. Coaching and consultation will be provided to the provider care team to support the use of collaborative care for behavior problems and ADHD. The TEAM intervention includes regular virtual meetings or calls with the providers (about once/month, on average) that cover core chronic care model functions, including registry use, case-finding, collaborative care team roles, and workflows outlining how DOCC is delivered in the practice.

DOCC with TEAM + LEAD implementation; DOCC with TEAM implementation

Implementation support strategies at the leadership level following standard implementation of DOCC BEHAVIORAL

Practices will learn and then deliver DOCC in treatment sessions with caregivers and/or children. Practice facilitation will be provided to practice leaders to help them support the care team's use of collaborative care for behavior problems and ADHD. The LEAD intervention includes regular virtual meetings or calls with practice leaders (about once/month, on average) that cover the assessment of practice capacity/barriers, ways to overcome organizational barriers and support staff use of DOCC, promoting innovation, and leveraging practice resources to support DOCC delivery and maintenance in the practice.

DOCC with LEAD implementation; DOCC with TEAM + LEAD implementation

DOCC: Evidence-based treatment for disruptive behavior and ADHD BEHAVIORAL

Practices will learn and then deliver DOCC in treatment sessions with caregivers and/or children. The content covers key topics related to the treatment of behavior problems (e.g., self-management, positive parenting) and ADHD (e.g., psychoeducation, medication).

DOCC with LEAD implementation; DOCC with TEAM + LEAD implementation; DOCC with TEAM implementation; DOCC with standard implementation (No TEAM or LEAD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PCP Participants:
• Employed at one of the up to twenty-four (24) pediatric primary care practices identified by the PA Medical Home Program at the PA AAP or by the University of Pittsburgh research team.
• Identified by the practice as a Primary Care Provider
• CM Participants:
• Employed at one of the up to twenty-four (24) pediatric primary care practices identified by the PA Medical Home Program at the PA AAP or by the University of Pittsburgh research team.
• Identified by the practice as a Behavioral Health Resource who delivers and coordinates behavioral health care in the practice, who will function in the study as a care manager.
• SL Participants:
• Employed at one of the up to twenty-four (24) pediatric primary care practices identified by the PA Medical Home Program at the PA AAP or by the University of Pittsburgh research team.
• Identified by the practice as the Senior Leader.
• Have a practice-level leadership role such as Medical Director or a clinical/practice leader
• Have administrative responsibilities related to patient care and/or the operations/management of the practice
• PM Participants:
• Employed at one of the up to twenty-four (24) pediatric primary care practices identified by the PA Medical Home Program at the PA AAP or by the University of Pittsburgh research team.
• Identified by the practice as the Practice Manager or equivalent position
• Are responsible for day-to-day practice operations, such as personnel management, billing, and compliance with regulations, in the pediatric practice.

You may not qualify if:

• Caregivers
• Already enrolled in the study as the caregiver to a different child (e.g., sibling) (Caregiver participants)

Sponsors & Collaborators

• University of Pittsburgh: lead
• American Academy of Pediatrics: collaborator
• Drexel University: collaborator
• NYU Langone Health: collaborator
• University of Michigan: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Pennsylvania American Academy of Pediatrics: collaborator

Study Sites (2)

Drexel University

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

RECRUITING

Related Publications (8)

• Kolko DJ, Campo JV, Kelleher K, Cheng Y. Improving access to care and clinical outcome for pediatric behavioral problems: a randomized trial of a nurse-administered intervention in primary care. J Dev Behav Pediatr. 2010 Jun;31(5):393-404. doi: 10.1097/DBP.0b013e3181dff307.

  PMID: 20495474 BACKGROUND

• Kolko DJ, Campo JV, Kilbourne AM, Kelleher K. Doctor-office collaborative care for pediatric behavioral problems: a preliminary clinical trial. Arch Pediatr Adolesc Med. 2012 Mar;166(3):224-31. doi: 10.1001/archpediatrics.2011.201. Epub 2011 Nov 7.

  PMID: 22064876 BACKGROUND

• Kolko DJ, Campo J, Kilbourne AM, Hart J, Sakolsky D, Wisniewski S. Collaborative care outcomes for pediatric behavioral health problems: a cluster randomized trial. Pediatrics. 2014 Apr;133(4):e981-92. doi: 10.1542/peds.2013-2516. Epub 2014 Mar 24.

  PMID: 24664093 BACKGROUND

• Kolko DJ, Hart JA, Campo J, Sakolsky D, Rounds J, Wolraich ML, Wisniewski SR. Effects of Collaborative Care for Comorbid Attention Deficit Hyperactivity Disorder Among Children With Behavior Problems in Pediatric Primary Care. Clin Pediatr (Phila). 2020 Jul;59(8):787-800. doi: 10.1177/0009922820920013.

  PMID: 32503395 BACKGROUND

• McGuier EA, Kolko DJ, Ramsook KA, Huh AS, Berkout OV, Campo JV. Effects of Primary Care Provider Characteristics on Changes in Behavioral Health Delivery During a Collaborative Care Trial. Acad Pediatr. 2020 Apr;20(3):399-404. doi: 10.1016/j.acap.2019.11.008. Epub 2019 Nov 21.

  PMID: 31760174 BACKGROUND

• Yu H, Kolko DJ, Torres E. Collaborative mental health care for pediatric behavior disorders in primary care: Does it reduce mental health care costs? Fam Syst Health. 2017 Mar;35(1):46-57. doi: 10.1037/fsh0000251.

  PMID: 28333516 BACKGROUND

• McGuier EA, Kolko DJ, Klem ML, Feldman J, Kinkler G, Diabes MA, Weingart LR, Wolk CB. Team functioning and implementation of innovations in healthcare and human service settings: a systematic review protocol. Syst Rev. 2021 Jun 26;10(1):189. doi: 10.1186/s13643-021-01747-w.

  PMID: 34174962 BACKGROUND

• Kolko DJ, McGuier EA, Turchi R, Thompson E, Iyengar S, Smith SN, Hoagwood K, Liebrecht C, Bennett IM, Powell BJ, Kelleher K, Silva M, Kilbourne AM. Care team and practice-level implementation strategies to optimize pediatric collaborative care: study protocol for a cluster-randomized hybrid type III trial. Implement Sci. 2022 Feb 22;17(1):20. doi: 10.1186/s13012-022-01195-7.

  PMID: 35193619 BACKGROUND

MeSH Terms

Conditions

Attention Deficit and Disruptive Behavior Disorders; Oppositional Defiant Disorder; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• David J Kolko, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin M Rumbarger, BA

CONTACT

4128867539; rumbargerkm@upmc.edu

David J Kolko, PhD

CONTACT

4122465888; kolkodj@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants are not directly informed of the implementation condition to which the practice site has been randomized. All formal standardized assessments will be conducted via secure electronic web-based data collection systems, limiting the potential for assessment bias. In the event that a caregiver requests that a staff member administer an assessment via phone, the assessor would be unaware of the implementation condition assigned to the child's practice where the caregiver receives care.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry, Psychology, Pediatrics, and Clinical and Translational Science

Model Details: The investigators propose a randomized trial using a factorial design to test effects of implementation support strategies on uptake of an evidence-based intervention (DOCC) in up to 24 primary care practices. Practices will receive DOCC training in accord with the Replicating Effective Programs model. Practices will be randomized to 1 of 4 implementation support conditions: 1) No TEAM/LEAD (training and technical support only); 2) provider care team consultation (TEAM); 3) practice leadership facilitation (LEAD); and 4) combination of provider care team and leadership implementation (TEAM+LEAD). Care teams in each practice will identify families and deliver DOCC to 20 caregivers and their children with externalizing behavior. Investigators will collect measures from 90 practice staff over 5 assessments (24 months) and 360 caregivers over 4 assessments (12 months) to support analyses.

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: June 30, 2021
• Study Start: November 28, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: These data will be released to the NDCT soon after each project's "main outcomes" manuscript is accepted for publication. The investigators plan to make these data available indefinitely, with no anticipated time limit.
• Access Criteria: In addition to public access to the NDCT, data can also be accessed by contacting the principal investigator.

Locations

US (2)